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Clinical Trials

The cost of bringing a new drug through its various stages, that is from its discovery through research until it might be available on the NHS may be as high as £500 million.

Several thousands of compounds are being researched at any one time from which only a handful will develop into a medication with a very real benefit and make it onto the world wide health systems, the path of research and proving a drug follows many stages.

 

Stage 1 Research.

Usually amongst natural substances ~ plants ~ fungus ~ flowers ~ foodstuffsstuffs etc. Seeking chemicals that have potential curative actions.

Stage 2 Uncovering Effect.

Analysing and testing of potential pharmaceuticals in the laboratory, separating potential compounds from useless compounds. Asking “do the seemingly potential compounds in a test tube have an effect against disorder”?

Stage 3 Pre Clinical Work.

When chemicals are considered to have  potential as a pharmaceutical they are then developed into a drug, it is a long and expensive process that leads to establishing a formula which is easily administered and is stable. Extensive animal studies take place at this stage. Once permission has been received for the compound to be tested in the human body it moves into three trial phases.

 

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Stage 4 Phase 1 Clinical Trial.

A small number of human volunteers are injected with various strengths of the proposed new medication under strict protocols.

Its purpose is not to discover whether the medication works but to study whether it is safe and how it reacts in the human body, how long it remains in the body and if there are any side / Serious effects.

Healthy human volunteers are recruited for this stage.

Stage 5 Phase 2 Clinical Trial.

The medication is then trialed on a number of sufferers of the disorder the drug is designed to treat.

This is to assess whether the medication really does help the disorder, to what extent and what dosages will be required.

Stage 6 Phase 3 Clinical Trial.

A larger trial is now undertaken amongst a greater number of sufferers recruited with the particular disorder undergoing investigation, usually held over a year to two years, some receive a placebo, some receive the medication, detailed information regarding those on the trial is scrupulously recorded the observations being;

 

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Bringing A Drug To Licence